AccessGUDID - DEVICE: Test-mate ChE Cholinesterase Test System (00860010612200)

GUDID

Device Identifier (DI) Information

Brand Name: Test-mate ChE Cholinesterase Test System
Version or Model: 400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400
Company Name: Eqm Research, Inc.

Primary DI Number: 00860010612200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 803114859 *Terms of Use

Device Description: For the quantitative determination of Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory technicians only. For use only with the AChE Assay Kit (Model 460) and the PChE Assay Kit (Model 470).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52964	Acetylcholinesterase IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the enzyme acetylcholinesterase in a clinical specimen, using a spectrophotometry method.	Active	false
36910	Photometer, absorbance/transmission, automated	An electrically-powered, automated, stand-alone laboratory instrument intended to be used to determine the absorbance or transmission of light energy transmitted through a substance, typically a solution/liquid (e.g., saliva, urine), or gas. It is used for diagnostic and/or research purposes and detects scattered light intensity, absorption and/or fluorescence.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DIH	Colorimetry, Cholinesterase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961656	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5d349146-90cd-48bd-9769-6502916e66b2
Public Version Date: August 08, 2023
Public Version Number: 1
DI Record Publish Date: July 31, 2023